Regulatory Affairs Specialist

2 semanas atrás


Brasília, Brasil Caderno Nacional Tempo inteiro

Segmento: Não Informado

Atividades

This role requires interaction with regulatory authorities to provide guidance on requirements and maintain awareness of current standards.

  • Maintain knowledge of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate collection and organization of data and information required by regulatory bodies, including preparation of study documentation.
  • Compile and prepare routine submissions filed to IRB/IEC/Third Body and Regulatory Authorities, liaising with them as applicable.
  • Liaise with internal and external vendors for regulatory authority submissions.
  • Perform review of final submission documents.
  • Ensure assigned start-up and maintenance activities are on track, meeting client expectations and regulatory requirements.
Requisitos
  • Required Skills and Qualifications: University degree (life science preferred) or certification in a related allied health profession, along with 2 years' work experience in clinical research.
  • Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
  • Familiarity with investigator start-up documents and contract/budget negotiation process.
  • Previous interaction with operational project teams and investigative sites.
Benefícios

General Office Environment.

Dados Adicionais

Dia s da Semana: Não Informado

Horário / Período: Não Informado

Os interessados devem se candidatar através do portal Caderno Nacional

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